Bupropion SR for Treating Smokeless Tobacco Use
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 225
- 试验地点
- 2
- 主要终点
- 7-day point-prevalence tobacco abstinence rate at week 12
研究概览
简要总结
To determine the efficacy and safety of bupropion SR for quitting tobacco in smokeless tobacco users.
详细描述
CONTEXT: No pharmacotherapies have been shown to increase long-term (≥ 6 month) tobacco abstinence rates among smokeless tobacco (ST) users, although bupropion SR has demonstrated potential efficacy in pilot studies.
OBJECTIVE
To determine the efficacy and safety of bupropion SR for tobacco abstinence among ST users compared with placebo.
DESIGN, SETTING, AND PARTICIPANTS: A randomized, double-blind, placebo-controlled trial conducted between August 2003 to May 2005 at two research centers with a 12-week treatment period and follow-up of smoking status to week 52.
INTERVENTION: Bupropion SR titrated to 150 mg twice daily or placebo for 12 weeks plus weekly behavioral interventions.
Main Outcome Measures: The primary endpoint was 7-day point-prevalence tobacco abstinence rate at week 12. Secondary outcomes included the prolonged and continuous tobacco abstinence rates at weeks 12, 24, and 52.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
- •used ST daily for at least one year
- •in good general health
- •willing to complete all study procedures
排除标准
- 未提供
结局指标
主要结局
7-day point-prevalence tobacco abstinence rate at week 12
次要结局
- prolonged and continuous tobacco abstinence rates at weeks 12, 24, and 52